The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.
CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
Cipla’s rollout of Lilly’s tirzepatide second brand comes as Wegovy price cuts tighten competition in India’s fast-growing GLP-1 market.
Responding to the newly-agreed EU pharma package, Medicines for Europe said the deal was a limited political compromise that could have been more ambitious – particularly when it comes to access – but nevertheless represented “an important step forward” and “progress” for the EU pharma sector.
“Section viii cannot function as Congress intended,” if a Federal Circuit ruling stands, the US solicitor general has argued as he urged the Supreme Court to review and reverse the closely-watched Hikma skinny-label Vascepa case.
Formycon has again stepped closer to financial certainty with another pembrolizumab biosimilar deal. This time, it unlocked a significant opportunity for the US and Canadian markets.
The US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.
Teva sees olanzapine LAI as key to building a schizophrenia franchise worth up to $2bn annually, following its earlier risperidone launch.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.
Delaware district court refuses to shorten 30-month stay, leaving Hopewell unable to launch its generic Mavenclad product.
The consolidation of Biocon-BBL is expected to unlock value, deliver operational synergies and provides BBL’s minority shareholders an 'earlier liquidity event'. Investor Viatris also signals accelerated expiration of biosimilars non-compete restrictions.
Cuban argues that user fees under the GDUFA program are deterring domestic production of generics, according to reports.
Collaboration aims to bring two biosimilars for osteoporosis and osteoarthritis to Mexico, with Saya leading commercialization and Enzene overseeing development and manufacturing.
After years of fighting and securing treatment for her daughter, cystic fibrosis campaigner Gayle Pledger could not leave other patients behind. This is a story of families coming together and finding a generic drug manufacturer in order to save their children.
While the long-awaited pembrolizumab biosimilar deal certainly boosts Formycon’s financials, it is unclear whether it will be enough to meet its annual guidance.
Partnership aims to improve yields, cut development time, and bring data-driven control to bioprocessing.
A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.
The FDA said an ANDA managed to be submitted during a period when no new ANDAs could be accepted.
In the wake of recent FDA guidance setting out a streamlined approach to biosimilar registration, developers have spent the past month responding. While most reactions have been enthusiastic, some firms have sounded a note of caution.